Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
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ClinicalTrials.gov Identifier: NCT01431352 |
Recruitment Status : Unknown
Verified November 2013 by Xiaoke Wu, Heilongjiang University of Chinese Medicine.
Recruitment status was: Recruiting
First Posted : September 9, 2011
Last Update Posted : November 5, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovary Syndrome | Drug: Letrozole Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 420 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Effects of Chinese Herbal Medicine and Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome:A Double-blind Randomized Controlled Trial |
Study Start Date : | September 2009 |
Estimated Primary Completion Date : | August 2014 |
Estimated Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Letrozole+ Chinese herbal medicine granules |
Drug: Letrozole
2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6. Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo twice a day for 6 month |
Placebo Comparator: Letrozole+ Chinese herbal medicine granules placebo |
Drug: Letrozole
2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6. |
- Live birth rate [ Time Frame: Up to 2 years ]
- Ovulation rate [ Time Frame: Up to 1 year ]
- Miscarriage rate [ Time Frame: Up to 1 year ]
- Change in hormonal profile [ Time Frame: Up to 1 year ]Follicle-stimulating hormone, luteinizing hormone, total testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulphate.
- Change in metabolic profile [ Time Frame: Up to 1 year ]glucose and insulin concentrations, cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol.
- Change in physical measurements [ Time Frame: Up to 1 year ]weight, vital signs, and hip and waist measurements.
- Pregnancy complications [ Time Frame: Up to 1 year ]gestational diabetes, pregnancy-induced hypertension, intrauterine growth retardation, ectopic pregnancy, congenital anomaly, preeclampsia, preterm labor, HELLP syndrome, preterm premature rupture of membranes, placental abruption, placenta accreta, placenta previa, postpartum hemorrhage, and others.
- Birth defects [ Time Frame: Up to 1 year ]
- Safety parameters [ Time Frame: Up to 1 year ]renal and liver function tests and complete blood count.
- Side effect profile [ Time Frame: Up to 1 year ]The major risks to the subject are side effects from letrozole and CHMG and the risks associated with pregnancy.

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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria
- Chinese women with PCOS. PCOS must have been diagnosed based on the presence of two of the following three Rotterdam criteria : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days.
- History of at least one year of infertility.
- Age between 20 and 40 years old.
- Normal semen analysis based on World Health Organization criteria (2010). The husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. A sperm concentration ≥15 × 106/mL and total motility ≥40% in the semen analysis of the husband was required for the woman to be included.
- Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy.
Exclusion criteria
- History of significant system diseases such as heart, lung, or kidney diseases.
- History of other endocrine disorders.
- Use of hormonal therapy, including metformin, in the past 3 months.
- Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431352
Contact: Lihui Hou, MD | 86-451-82130094 | houlihui2007@hotmail.com | |
Contact: Xiaoke Wu, MD. PhD | 86-451-82130094 | xiaokewu2002@vip.sina.com |

Responsible Party: | Xiaoke Wu, Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital, Heilongjiang University of Chinese Medicine |
ClinicalTrials.gov Identifier: | NCT01431352 |
Other Study ID Numbers: |
Letrozole |
First Posted: | September 9, 2011 Key Record Dates |
Last Update Posted: | November 5, 2013 |
Last Verified: | November 2013 |
Polycystic ovary syndrome Randomized controlled trial Chinese herbal medicine |
Chinese herbal medicine granules Letrozole Live birth |
Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |
Letrozole Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |